Last Updated on October 15, 2024 by The Health Master
Drug recall
Drug recall: In New Castle, Delaware, Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125 mg, and one lot of Digoxin Tablets USP, 0.25 mg, to the consumer level due to a label mix-Up.
- Bottles of Digoxin Tablets, USP 0.125mg, are incorrectly labeled and contain Digoxin Tablets, USP, 0.25mg.
- Bottles of Digoxin Tablets USP, 0.25 mg, are incorrectly labeled and contain Digoxin Tablets USP, 0.125mg.
- Digoxin Tablets USP, 0.125 mg, are yellow, circular, beveled, uncoated tablets scored between “N” and “201” on one side and plain on the other side.
- Digoxin Tablets USP, 0.25 mg, are white to off-white, circular. beveled, uncoated tablets scored between “N” and “202” on one side and plain on the other side.
Risk Statement:
The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose.
Patients who intend to take Digoxin Tablets USP, 0.125mg, but unknowingly take Digoxin 0.25 mg, will receive a super potent dose and can experience significant drug toxicity (mental disorientation, dizziness, blurred vision, memory loss, and fainting) from the unintentional overdose.
Patients who intend to take Digoxin Tablets USP, 0.25mg, but unknowingly take Digoxin 0.125mg would receive a sub potent dose, which may lead to loss of control of heart rate and a potential heart failure exacerbation.
Marlex Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall.
Product usage
- The product is used for the treatment of mild to moderate heart failure.
- Digoxin increases heart muscle contraction in pediatric patients with heart failure.
- Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
Product details
The product is packaged as 100 tablets in white HDPE bottles and labeled as indicated below with the NDC, lot, and expiration date.
- Digoxin 0.125mg Tablet, NDC 10135-0747-01, lot# E3810, expiration 2/2025
- Digoxin 0.25mg Tablet, NDC 10135-0748-01, lot# E3811, expiration 2/2025
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Drug recall: Glenmark recalls this High BP drug due to quality reasons
Drug recall: Alembic, Aurobindo recall these drugs for this reason
Drug recall: Lupin Pharma recalled these Birth Control Pills
Drug recall: Sun Pharma, Alembic recall these drugs due to this reason
Drug recall: Dronabinol Capsules, Ziprasidone HCL Capsules recalled due to this reason
Medical drugs found in groundwater of pharma hub: Hyderabad
Pharmaceutical Manufacturing Standards in India: A Focus on GMP Compliance
Blood Centre under Scrutiny: HIV-Positive Blood units issued
USFDA approval issued for Mycophenolate Mofetil for Oral Suspension
Serious violations uncovered during Inspection of Medical Stores
Anil Mittal promoted as Registrar cum Secretary at the PCI
USFDA approval granted for Topiramate ER Capsules
Pharma Industry online Certification Process starts: Gujarat
NABL certification for Laboratories: Let’s understand
FAQs – On Narcotic Drugs, Brand Names of drug
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
